Diaphragm entry for posterior surgical access

ABSTRACT

Methods and devices described herein facilitate improved treatment of body organs.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/558,417, filed on Nov. 9, 2006, now issued U.S. Pat. No. 8,721,597,the content of which is incorporated herein by reference in itsentirety.

BACKGROUND OF THE INVENTION

1. Field of the Inventions

Embodiments of the invention relate to methods for minimally invasivesurgery and devices useful in such methods. More particularly, methodsand devices described herein permit improved access within a body cavityto perform a surgical procedure, for example ablation and/or coagulationof cardiac tissue during minimally invasive surgical access to theheart. The diaphragmatic access described provides direct visualizationof anatomic structures within the thoracic cavity such as the posteriorleft atrium, the posterior side of pulmonary veins, or any other suchanatomic structure. In some variations, accessing the thoracic cavity inthis manner facilitates manipulation of a coagulation probe to reliablycreate transmural, curvilinear lesions capable of preventing thepropagation of wavelets that initiate and sustain atrial fibrillation,atrial flutter, ventricular tachycardia, or other arrhythmia substrate.

2. Description of the Related Art

Currently, procedures that provide access to the thoracic body cavityinvolve incisions through the chest wall. For example, such proceduresinclude median sternotomy, thoracotomy, thoracostomy, ormini-sternotomy. Typically, these surgical techniques require deflationor retraction of the lungs to access the heart and/or other organswithin the thoracic space.

A median sternotomy provides the most exposure for the physician. Inthis procedure the surgeon creates a midline incision through thesternum that cuts along the bone separating it into two sections. With amedian sternotomy, although the heart can be lifted and manipulated byhand, the posterior surface of the heart or other organs is still notreadily visible unless the heart is significantly rotated or lifted.However, significant rotation or lifting of the heart may causeundesirable hemodynamic issues during beating heart procedures. Afterthe procedure, the surgeon closes the median sternotomy with largediameter metal wires. The rejoined tissue must be held stable during thehealing process, similar to a bone fracture that must remain immobileduring rehabilitation. Any coughing or dramatic movement is extremelypainful to the patient because the chest moves. Clearly, rehabilitationafter the medial sternotomy requires a significant amount of time.

Thoracotomy techniques involve creating large (or small withminithoracotomy) incisions between the ribs to gain access to thethoracic cavity. After the incision, the surgeon separates the ribs witha rib spreader to produce space for insertion of various instruments.The muscles that overlay the chest must be cut during the thoracotomy.Much of the pain during the rehabilitation process is due to the cuttingof the muscles. A thoracotomy provides limited access and visualizationto the heart unless endoscopes are used. Yet, even the use of endoscopesprovides limited access to the posterior regions of the heart and lungsbecause these organs cannot be lifted or rotated easily.

Thoracostomy techniques use ports through the space created during thethoracotomy. The surgeon uses trocars (e.g. 6-10 mm) to access thethoracic cavity. Access to the anterior surface of the heart isgenerally sufficient with this technique. However, this technique doesnot provide ready access or visualization of posterior regions of theheart or other organs.

In subxyphoid techniques, the surgeon creates an incision below thexyphoid process but above the diaphragm. This technique is common forpericardiocentesis where blood is removed from the pericardial cavityduring a pericardial effusion or tamponade. The diaphragm provides abarrier and hindrance to manipulating the heart or accessing theposterior heart surface during subxyphoid techniques. Accordingly,subxyphoid techniques are often limited to procedures that target theanterior or apical ventricular regions.

The conventional surgical techniques discussed do not provide themedical practitioner with sufficient visibility of anatomic structureswithin the thoracic cavity. For example, these procedures do not providesufficient visibility for anatomic structures located along or adjacentto the posterior surface of the heart or lungs. In order to obtain suchvisibility, the patient must be placed on cardiopulmonary bypasssupport. Then the surgeon must create a large incision in the patient'schest through which the patient's heart and lungs can be lifted and/orrotated. Accordingly, surgical practitioners may be hesitant to treattissues located along or adjacent to the posterior heart or lungs duringless invasive procedures, given the inability to visually observe thetarget area. As such, minimally invasive cardiothoracic surgery has beenlimited to those anatomic structures located along the anterior surfaceof the heart.

Atrial fibrillation surgery is just one example of a surgical procedurethat, while it relies on the surgical techniques discussed above, theprocedure also suffers from shortcomings due to a lack of access toorgans within the thoracic cavity. Atrial fibrillation surgery involvingradiofrequency, DC, microwave, ultrasound, laser or other modes ofthermal ablation of atrial tissue has a limitation where tissue contactthroughout the length of the electrode(s) is/are not consistent. Suchinconsistent electrode contact causes variability in the transmission ofenergy throughout the target length of ablated/coagulated tissue. Thisinconsistency also produces undesirable gaps of viable tissue thatpromote propagation of wavelets that sustain atrial fibrillation, orproduce atrial flutter, atrial tachycardia, or other arrhythmiasubstrate. Target tissue regions that reside along the posterior surfaceof the heart is one factor that contributes to inconsistent electrodecontact. As discussed above, conventional means of surgical access arenot optimal to access the posterior surfaces.

Another factor that contributes to the inability of existing thermalablation probes to create complete curvilinear, transmural lesions isthe presence of convective cooling on the opposite surface of theatrium. This convective cooling produces a heat sink that decreases themaximum temperature at the surface thereby preventing the lesions fromconsistently extending transmural through the entire wall of the atrium.This phenomenon is especially significant during beating-heart therapieswhere the surgeon places the coagulation/ablation probe against theepicardial surface. However, because blood is still flowing along theendocardium, the blood removes heat. Heat convection produces a largertemperature gradient between tissue immediately under the probeelectrodes along the epicardium and tissue at the endocardium. Increasedtissue contact is capable of reversing this effect through compressionof the tissue. This reduces the effective the wall thickness of theatria, ensuring consistent contact throughout the length of theelectrode(s), and increasing the efficiency of thermal conduction fromthe epicardium to the endocardium creating a more consistent andreliable lesion.

Another deficiency of current approaches is the inability to direct thecoagulation to precise regions of soft tissue while avoiding underlyingor nearby tissue structures. For example, atrial fibrillation ablationmay involve extending a lesion to the annulus near where the circumflex,right coronary artery and coronary sinus reside. In another example,atrial fibrillation involves ablating ventricular tachycardia substratesresiding near the coronary arteries or coronary veins. In a thirdexample, the esophagus resides along the posterior left atrium betweenthe left and right pulmonary veins; unanticipated heating of theesophagus during atrial fibrillation treatment can produce esophagealfistulas which can be associated with high morbidity and mortalityrates. Conventional approaches cannot selectively ablate the desiredsoft tissue structures while isolating other tissue structures that areintended to be preserved from targeted regions.

The improved methods and devices described herein offer improved accessto tissue regions within the body, especially those organs in thethoracic cavity. Variations of these methods and devices address theabove described deficiencies for atrial fibrillation and ventriculartachycardia ablation. In addition, the embodiments or variations of theembodiments may address similar deficiencies, which are apparent duringother applications involving coagulation of a selected tissue region ina precise manner.

SUMMARY OF THE INVENTION

The devices described herein allow for creating a temporary cavitybetween organs in a body. Generally, the devices include an elongatemember having at least one working channel extending therethrough, theelongate member having a distal portion adapted for insertion into thebody and a proximal portion, the elongate member having sufficientcolumn strength to allow insertion of the distal portion between organs,at least one opening at a distal end of the elongate member, where theworking channel(s) exits the elongate member at the opening(s), and afirst expandable member adjacent to the distal portion adapted to expandabout the elongate member, where upon expansion between organs the firstexpandable member separates the organs to form the temporary cavityaround the opening(s). The devices can also have a rail-member thatassists in positioning of treatment devices and/or manipulation oftissue structures within the body.

In variations of the invention, an access device may have an additionalworking channel (referred to as a working lumen) that is intended toallow insertion and removal of various devices in the main workingchannel without disturbing a device (e.g., a scope) that is left at thesurgical site in the working lumen (i.e., separate).

Variations of the access device include expandable members that areconfigured to expand non-uniformly about the elongate member. Asdiscussed below, this configuration may permit improved formation of atemporary cavity.

In another variation, the elongate body may be tapered increasingly froma distal portion to the proximal portion. This tapering provides severaladvantages such as: causing natural separation of organs as the elongatemember is further advanced between organs, facilitating easiermanipulation of multiple instruments through the elongate member (giventhe larger size of the proximal working channel), and increases themaneuverability of instruments within the elongate member.

The devices may also include a proximal portion of the elongate memberthat allows manipulation of the access device outside of the body. Forexample, the proximal portion may have one or more handles or grips thatare commonly known and used in medical devices.

The access devices described herein may be constructed to have lengthsthat are slightly greater than the lengths of standard scopes. In thismanner, a scope advanced through the device will be placed at thetemporary cavity, reducing the risk that the scope may be advancedthrough the temporary cavity and cause unintended damage.

Variations of the device further include one or more shapeable supportmembers coupled to the elongate member, where the shapeable supportmember causes the elongated member to retain a shape of the shapeablesupport member. The shapeable support member may be placed in a supportlumen. In one example, a shapeable support may be formed or shapedoutside of the device by the medical practitioner. Upon achieving thedesired shape, the support member is advanced within the support lumencausing the device to conform to the desired shape.

The expandable members described herein include balloons, or strand-likesupport members. Any number of expandable members may be used on adevice. In some variations, the expandable support member (or a portionthereof) extends beyond the distal end of the elongate member. Thisfeature permits clearance between the end of the device and body tissueor fluids.

The balloons or support members described herein may be of any shape asdescribed below. In addition, the expandable members may includefeatures (e.g., grooves, coatings, etc.) that assist in separating,elevating and/or stabilizing tissue or organs. The expandable membersmay be expanded independently of each other or may be constructed toexpand together.

The devices described herein may include any number of suction ports atthe end or within the working channel of a device. Furthermore, thedevice may include visualization elements to aid in observing thesurgical platform in the temporary cavity.

The devices described herein may also include locking features thatassist in securing the device within the body. For example, the devicemay include a set of locking balloons located proximally on the elongatemember where the balloons secure the device within the body or to anoutside surface of the body just adjacent to the incision.

Variations of access devices also include expandable members that areslidable into and out of the elongate member. These expandable membersmay have any number of sets of arms that separate and elevate organs tocreate the temporary cavity.

Methods are also described herein. For example, the methods permitaccessing a body organ in a patient via a minimally invasive procedure,by advancing an access device through an opening in the patient, wherethe access device comprises at least at least one working channel and anexpandable member on an exterior of the device, forming a temporarycavity by actuating the expandable member to separate adjacent tissuestructures, positioning a rail-member in the temporary cavity, where therail-member includes a far section that is affixed relative to theaccess device, and moving a near section of the rail-member distallyrelative to the access device such that a mid section of the rail-memberforms an arcuate profile distal to the access device and over oradjacent to the body organ.

The methods may include advancing the access device through a diaphragm.In such a case, the device is advanced through a first incision in anabdomen of the patient creating an opening in the diaphragm, andadvancing the access device through the diaphragm into the thoraciccavity. The methods include use of a visualization system coupled to theworking channel or inserting a scope-type device into the workingchannel to provide visual access to the posterior surface of the organ.

The methods described herein include creating a temporary cavity onsurfaces of the heart where the access device is placed in the thoraciccavity between the heart and spine. The temporary cavity may be formedon other organs such as an esophagus, and actuating the expandablemember to separate the esophagus from esophageal vessels.

Methods are also described to treat a body organ in a thoracic cavity ofa patient via a minimally invasive procedure by accessing a diaphragmthrough a first incision in an abdomen of the patient, placing a devicehaving at least one ultrasound transducer coupled thereto against asurface of the diaphragm, and applying ultrasound energy through thediaphragm to tissue within the thoracic cavity.

Another variation of the invention includes a system for treating tissuein the body, the system comprising, an access device having an elongatemember having a working channel extending therethrough, the elongatemember having a distal portion adapted for insertion into the body and aproximal portion, the elongate member having a column strength to allowinsertion of the distal portion between organs, an opening at a distalend of the elongate member, where the working channel exits the elongatemember at the opening, a rail-member having a far section, a nearsection, and a mid section located therebetween, where the far sectionis affixed relative to the elongate member, the near section beingmoveable relative to the elongate member, such that distal movement ofthe near section causes the mid-section of the rail-member to assume anarcuate profile distally to the opening, a first expandable memberlocated at the distal portion and adapted to expand about the elongatemember, where upon expansion between organs the first expandable memberseparates the organs to form the temporary cavity around the opening,and a coagulation device having a guide lumen extending through aportion of a body, the coagulation device having an electrode, where theguide-lumen advanceable over the rail member such that the coagulationdevice assumes the arcuate profile of the mid-section of the railmember.

The subject matter of this application may be incorporated with thesubject matter in the following applications: U.S. patent applicationSer. No. 11/208,465 entitled “Vacuum Coagulation & Dissection Probes”;U.S. patent application Ser. No. 10/425,251 entitled “Vacuum CoagulationProbes”; U.S. Provisional application No. 60/726,342 entitled DiaphragmEntry for Posterior Access Surgical Procedures; and U.S. Pat. No.6,893,442 the entirety of each of which is hereby incorporated byreference in their entireties.

Variations of the access device and procedures described herein includecombinations of features of the various embodiments or combination ofthe embodiments themselves wherever possible.

BRIEF DESCRIPTION OF DRAWINGS

FIGS. 1A and 1B show top views of patients with two Diaphragm Accessprocess embodiments of accessing the thoracic cavity to manipulatecoagulation, dissection, and visualization devices;

FIGS. 1C and 1D show a partial side view of the thoracic cavity anddemonstrates an example of insertion of an access device into theabdominal space and ultimately into the thoracic cavity;

FIGS. 2A to 2C show side sectional views of a thoracic cavity with avariation of an access device used to separate the heart from posterioranatomy;

FIGS. 3A to 3C show side views of a thorax with a device as describedherein defining a temporary cavity through which surgical devices may bemanipulated during a surgical procedure;

FIGS. 3D to 3F show side views of a thorax to illustrate accessing aposterior atrial surface around pulmonary veins without having todissect tissue around the pulmonary veins;

FIG. 4A shows a variation of an access device placing an ultrasounddevice against a diaphragm;

FIG. 4B shows an example of an access device separating the esophagusfrom associated vessels;

FIGS. 5A to 5C show side views of a patient with three processes ofaccessing the thoracic cavity to manipulate coagulation, dissection, andvisualization devices;

FIG. 5D shows a top view of a patient positioned on the operating tableduring a Diaphragm Entry for Posterior Access procedure of theinvention;

FIGS. 6A to 6D show a perspective view of the posterior heart withlesions created via a Diaphragm Entry for Posterior Access processembodiment of the invention;

FIGS. 7A to 7C show a top view, a side-sectional view, and across-sectional view of an variation of an access device for use asdescribed herein;

FIGS. 7D to 7E show another variation of an access device having atapered elongate member;

FIGS. 7F to 7I show variations of an access device having a workingchannel and a second working lumen;

FIG. 7J show a variation of an access device where the working channeland second working lumen are offset at the proximal end of the device;

FIGS. 8A to 8C show a top view, a side view, and a bottom view ofanother variation of an access device;

FIGS. 9A to 9D show front and side-sectional views of an access deviceusing stabilizer members and stabilizer members within a balloon;

FIGS. 10A to 10C show a top view, a side view, and a bottom view of anaccess device having multiple stabilizer strands as expanding andstabilizing members;

FIGS. 11A and 11B show a top view and a front view of an access devicewhen the stabilizer members are in a compressed, low profileconfiguration;

FIGS. 11C and 11D show a side view and a front view of the access deviceof FIGS. 11A and 11B in an expanded configuration;

FIGS. 12A to 12C show a side view, an end view, and an isometric view ofan access device having multiple balloons;

FIGS. 12D to 12J show additional variations of access devices;

FIGS. 13A to 13C show perspective views of a dissecting instrumentembodiment manipulated during the Diaphragm Entry for Posterior Accessprocess of the invention to further define a cavity into whichinstruments may be manipulated;

FIG. 14A shows a side view of a dissecting instrument embodiment in anon-actuated configuration;

FIG. 14B shows a side view of the dissecting instrument in FIG. 14A inan actuated configuration;

FIGS. 14C and 14D show cross-sectional views taken along section A-A andB-B through the dissecting instrument in FIG. 14A;

FIGS. 14E to 14G show side views of alternative dissecting jawembodiments;

FIGS. 15A to 15D show side views of alternative dissecting jawembodiments;

FIGS. 16A to 16D show a top view, a side view, a perspective view, and abottom view of an appendage grasper embodiment;

FIGS. 17A to 17C show side views of an atrial appendage closed during aDiaphragm Entry for Posterior Access process;

FIGS. 18A to 18C and 19A to 19B show additional variations of an accessdevice where the expandable member is slidable out of the elongatemember;

FIGS. 20A to 20B show an additional variation of an access device thatis configured for use in a variety of traditional entry procedures;

FIGS. 21A to 21C illustrate additional aspects of the access devices asdescribed herein;

FIGS. 22A to 22C show a rail-member of the access device advancing outof the access device and a treatment device being advanced over therail-member;

FIGS. 23A to 23B show additional variations of access devices havingrail-members;

FIG. 23C shows features that allow a user to selectively locate arail-member relative to an access device;

FIGS. 24A to 24C illustrates a rail-member advanced to a target site andan arcuate profile or path so that a treatment device can be advancedover the rail member for treatment of the tissue;

FIG. 25 illustrates an example of a lesion pattern created withoutdissection of pericardial reflections.

DETAILED DESCRIPTION

Methods and devices described herein provide for improved manipulationof organs and/or instruments in the thoracic cavity. The methods anddevices may allow for direct visualization along the posterior region ofthe heart and other anatomic structures not attainable with conventionalthoracic approaches. In one instance, the access devices describedherein can be combined with a rail-member for accurate positioning oftreatment devices over tissue.

Furthermore, the methods and devices described herein may be used inconjunction with, or as an alternative to the conventional approachesdescribed herein. In general, the surgical approaches and proceduresdescribed herein rely on entry through the diaphragm of a patient toaccess a posterior region of that patient (the procedure hereafterreferred to as “Diaphragm Entry for Posterior Access” or simply “DEPA”).The DEPA procedure may also be referred as VAPS (Video-AssistedPericardiac Surgery) or TAPS (Trans-Abdominal Pericardiac Surgery).

FIGS. 1A to 1B show examples of placement of access devices 182 (alsoreferred to as a separator or an elevator herein) under the methods forposterior access. Once a patient is prepared, as discussed in theexamples below, an access device 182 is inserted through, at least afirst, an abdominal, incision 168. The device is then advanced throughthe diaphragm (not shown) and placed adjacent or between organs forcreation of a temporary cavity. FIG. 1A illustrates one example, in thisvariation; the surgeon places the access 182 between heart and the spinesuch that the esophagus can be separated from the posterior surface ofthe heart.

As shown in FIG. 1A, the method may be augmented with one or twoadditional thoracostomy incisions allowing for placement of trocars 106into the thoracic cavity. The trocars 106 permit insertion of surgicaltools or visualization devices. Accordingly, the access device 168allows for direct visualization of the posterior surface of the organsduring manipulation of the instruments inserted through the right and/orleft thoracostomy access ports 106. Moreover, use of the additionalthoracostomy access sites with the access device 168 may permit thesurgeon to visualize the anterior surfaces of anatomic structures,during the procedure. Once tissue obscures the surgical site from thesurgeon's view via the thoracostomy access ports 106, the access device168 allows the surgeon to have a posterior view of the surgical site. Asshown in FIG. 1B, variations of the methods described herein includeposterior access techniques using an access device 168 withoutadditional thoracostomy access ports.

FIGS. 1C to 1D illustrate partial cross sectional views of a patient'sthoracic cavity and abdomen to demonstrate a general principle of theDEPA procedure. For the sake of clarity, certain organs are not shown inthe figures. FIG. 1C illustrates the DEPA procedure after the patient isprepared (as discussed herein) and after the DEPA incision is madewithin the abdomen. As shown, the DEPA incision allows entry of anaccess device 182 within the abdominal space and adjacent to a diaphragm170. An incision in the diaphragm may be made using cutting featuresincorporated in the access device 182, a tool advanced through theaccess device 182, or via another tool advanced through anotherabdominal port or a thoracostomy port.

FIG. 1D shows an example of an access device 182 as it creates atemporary space within the thoracic cavity by separating the posteriorventricular surface 190 of the heart from the spine 218 and esophagus220. As discussed below, the methods described herein contemplatecreation of a temporary cavity about any organ such that the accessdevice separates one or more additional organs from the desired surgicalspace. FIG. 1D shows the expansion of expandable members 212 (e.g., asdiscussed below: inflatable bladders, expandable strands, etc.) toseparate adjacent tissues and form a temporary cavity. In the variationshown, the access device 182 creates the temporary cavity at a posteriorsurface of the heart. As described below, the temporary cavity may beformed where needed including the various other organs and/or tissuesurfaces within the body. This temporary cavity permits improvedsurgical and visual access to various tissue surfaces without the use ofcomplex equipment. In general, the improved access provides the surgeonthe ability to perform additional procedures that would otherwise bedifficult or impossible.

FIGS. 2A to 2C illustrate side-sectional side views of the access device182 when inserted through an opening in the diaphragm 240. As shown, theaccess device 182 enters the patient through an abdominal incision 168below the diaphragm 170. The device 182 then advances through diaphragm(e.g., via an incision 240) to access the posterior organ surfaces. Asnoted below, the access device 182 defines a tube 210 having at leastone working channel 211 through which the instruments can be insertedand manipulated. A scope 184 (hereafter a “DEPA scope”) can be used tovisualize a substantial portion of the posterior heart (posterior atrium188 and posterior ventricle 190) and/or other organs/tissue. Typically,the scope 184 transmits an image to an external monitor 181. Once thesurgeon positions the device 182, expandable members 212 on the devicemay be actuated to create a temporary cavity within the body. In thisvariation, the expandable members 212 comprise inflatable bladders orballoons that expose a posterior atrial surface 188 and a posteriorventricular surface 190 of the heart.

As shown in FIG. 2A, entry into the thoracic cavity via the diaphragmallows the access device 182 to form a smooth transition/angle from theaccess site into the patient to the posterior surface of the organs inthe thoracic cavity (e.g., heart, lungs, esophagus, etc.). Thetraditional approaches mentioned above require multiple steep anglesthat require excessive manipulation of devices and do not offervisualization without complex equipment. Such equipment introducessignificant difficulty in manipulation and viewing perspective. Theangle of entry provided by the access device 182 via the diaphragm 170allows use of a straight scope, having a viewing angle between 0 and 60degrees, to visualize the posterior surface of the organs. Flexiblescopes may be used but are not necessary because of the smoothtransition and shallow angle of insertion from the skin puncture site tothe diaphragm incision adjacent the posterior heart surface.

Yet another benefit provided by the entry method of FIG. 2A is that asurgeon may manipulate instruments within the thoracic cavity in aneasier and more controllable manner. For example, use of conventionaltechniques requires that a surgeon operate with a device having a near90 degrees bend. Manipulation of such a device is difficult sincepushing down directs the device away from tissue and the organs withinthe thoracic cavity interfere with the device when pulled upward. Use ofrelatively complex steerable equipment introduces complexity as well asreduces the surgeon's tactile feedback.

FIG. 2B illustrates the access device 182 positioned in the thoraciccavity as the surgeon manipulates a surgical tool 124 in the thoraciccavity. As shown, the DEPA scope 184 allows posterior visualization ofthe surgical site. In many cases it is important to keep the visualfield clear from fluids. Accordingly, the access device 182 may have anaspiration tube 252 or separate aspiration lumen to draw fluids from thesurgical site.

FIGS. 3A to 3B, illustrate another variation of an access device 182. Asshown in FIG. 3A, the device 182 includes expandable member 216 in theform of expandable stabilizer strands 216. Alternatively, as describedabove, the expandable member may comprise a set of balloons or bladders.FIG. 2C illustrates another variation where the surgeon positions theaccess device 182 in the thoracic cavity. However, in this variation,the surgeon may also use a second scope 184 advanced in a conventionalmanner as discussed above (e.g., through trocars 106 as shown in FIG.1A). The purpose of the second scope 184 is to view the anterior surfaceof the organs. This arrangement allows visualization of the anterior andposterior surfaces of the organ. Accordingly, as a surgeon performs aprocedure on an anterior or posterior surface, as the surgeon breaksthrough to the opposite surface (i.e., the posterior or anteriorsurface) use of the two scopes 182 and 184 improves visualization. Inone example, the DEPA scope may be used merely for posteriorvisualization during a video assisted thoracostomy procedure.

FIG. 3A to 3B, illustrate another variation of an access device 182. Asshown in FIG. 3A, the device 182 includes expandable member 216 in theform of expandable stabilizer strands 216. Once the surgeon positionsthe access 182 device in place, the expandable members 216 actuate toseparate the organs and define a temporary cavity. Once the surgeoncompletes the procedure, the expandable member 216 collapses, therebycausing closure of the temporary cavity. In this variation, theexpandable members 216 separate the esophagus 220 from the descendingaorta 242 while also stabilizing both organs. This action serves toprotect these anatomic structures while defining the temporary cavity.

FIG. 3B illustrates placement of an ablation device 2 (e.g., as thosedescribed herein) through the working channel(s) 211 of the device 182.As shown, the temporary cavity permits visualization of a posteriorsurface of the organ (in this case the heart). This action allows thesurgeon to ablate or treat the posterior surfaces of the heart. Forexample, the surgeon may treat the pulmonary veins located on theposterior surfaces on the heart without having to dissect the veins fromthe heart. As noted above, to keep the visual field clear from fluids,the access device 182 may have an aspiration tube or separate aspirationlumen to draw fluids from the surgical site.

Without posterior access, a surgeon would have to dissect the veins awayfrom the heart's surface and then attempt to perform the procedure. Evenin such a case, without posterior visualization, the surgeon is forcedto treat portions of the veins blindly. On the other hand, a surgeonusing a scope-type device (such as a DEPA scope 184 as described above),as shown in FIG. 3C, can directly visualize the posterior surfaces ofthe heart and veins during the treatment.

Another technique made possible through use of the access device 182 anddiaphragm entry is that the surgeon can create a lesion on each side ofa pulmonary vein (and in fact, an entire lesion pattern capable oftreating atrial fibrillation) without having to dissect the pulmonaryveins from the pulmonary artery, superior vena cava, or pericardium. Theaccess device 182, as shown in FIG. 3B, allows the surgeon to reach theinferior surface of the pulmonary veins 189 located on the posterioratrial surface 188. Therefore, the surgeon has access along each side ofthe left pulmonary veins, and each side of the right pulmonary veins.Furthermore, the surgeon may apply additional lesions to the posteriorsurface of the heart with minimal or no dissection of the pulmonaryveins.

FIG. 3C also shows another variation of the DEPA methods, where anaccess device 182 separates adjacent tissue to create a temporarycavity. The surgeon then may advance treatment devices 2 andvisualization devices (e.g., an endoscope 184) to the temporary cavitybut external to the access device 182. As shown, the treatment device 2permits creation of a lesion on the posterior surface of the heart andon the pulmonary veins. In this variation, the access device 182 usesstabilizer strands 216, however, any variation of device may be used.

FIGS. 3D to 3F illustrate another variation of a DEPA method that ismade possible because of access to the posterior region of the heart. Asnoted above, conventional approaches intending to apply coagulationdevices to a posterior surface of the heart requires dissection oftissue to access the posterior surface. Typically, when the surgeonintends to create a coagulation line around the atrial surface adjacentto the pulmonary vein, the coagulation device is inserted around thepulmonary vein that is dissected from cardiac tissue. Because the DEPAmethod provides direct access to the posterior surface of the heart, thepulmonary veins and surrounding atrial surface are directly visible andaccessible without dissection of tissue. As shown in FIG. 3D, atreatment device 2 can access the posterior atrial surface 188, in thiscase around the pulmonary veins 164, without having to dissect tissue.

FIG. 3D, illustrates a variation of a treatment device 2 that has twoopposing c-type electrodes. This device allows formation of acoagulation line around the pulmonary veins. FIGS. 3E and 3F illustratetreatment devices 2 using a single c-type electrode configuration toform coagulation lines on the atrial surface 188 around each side of thepulmonary veins 164.

FIG. 4A illustrates another variation of a diaphragm-approach fortreatment of tissue structures within the thoracic cavity. This approachis capable of treating thoracic tissue contacting the diaphragm withoutpenetrating the diaphragm. The access device 182 advances to thediaphragm 240 without penetrating it. Next, the surgeon places anultrasound-device 254 (or other ablation energy emitted by a devicecapable of focusing enough energy to heat tissue at distance greaterthan 1 inch from the device) having at least one ultrasound transduceragainst a surface of the diaphragm. The ultrasound device 254 focusesenergy beyond the diaphragm 240 allowing for organs (e.g., heart tissue)to be treated without entering the thoracic cavity. In one example, theultrasound-device 254 may use high frequency ultrasound (commonlyreferred to as HIFU) to treat structures through the diaphragm. In onevariation, the HIFU device has an active surface of several transducersarranged in a phased array which are capable of radiating focusedtherapeutic ultrasound energy at a fixed distance. The transducer itselfmay alternatively be capable of providing the focused ultrasound withoutrequiring several transducers operating together.

In one variation, the ultrasound device 254 may contact the diaphragmadjacent to the right and left ventricles. The surgeon may then localizelesions and ablate tissue in the heart by transmitting ultrasoundthrough the HIFU probe without having to penetrate into the thoraciccavity. In an additional variation, the ultrasound device 254 willincorporate a vacuum coupling and covering capable of forming a fluidtight seal with the diaphragm and use suction to engage the HIFU probeagainst the diaphragm thereby ensuring transmission of HIFU to thecardiac tissue without having interference of air or bone. Additionalinformation regarding HIFU may be found on www.ushifu.com orwww.internationalhifu.com.

FIG. 4B illustrates another variation of a diaphragm-approach fortreatment of tissue structures within the thoracic cavity. In thisvariation, the access device 182 is used to dissect the esophagus 220from esophageal vessels 221. As described in an example below, once thevessels 221 are sufficiently dissected from the esophagus, the accessdevice may create a temporary cavity on a surface of the esophagus 220by moving it away from the vessels 221.

In another variation of the method, the ultrasound-device 254 may beused to generate an image of perfusion patterns in the ventricles. Thesurgeon may use this imaging to identify slow conduction zones on theborder of infarcted tissue. Such an approach may be used to treatventricular tachycardia by mapping the perfusion flow patterns throughthe ventricular tissue and destroy those areas of tissue thought tocause the tachycardia. Regions responsible for inducing or maintainingventricular tachyarrhythmias have been demonstrated to frequently occurin regions of slow and interspersed perfusion that can be delineatedfrom completely infarcted tissue or viable tissue. Once these regionsare identified, the high frequency ultrasound or any other energymodality and implementation design capable of focusing energy into localareas spaced at known distances from the ablation device (in this casetargeting tissue in the ventricles from the diaphragm) are used toablate the imaged slow or interspersed perfusion patterns and eliminatepotential substrates of ventricular tachycardias.

Direct visualization of the posterior heart surface (or the esophagus orthe lung) provides the surgeon with confidence when manipulatinginstruments along the cavity between the heart and lungs, and the spineand esophagus. An additional benefit of the DEPA process and associateddevices is the ease of deployment due to the direct line to theposterior surface of the anatomy and the rapid healing post-proceduredue to the absence of or limited deflation or other manipulation of thelungs when manipulating instruments along the posterior heart, theesophagus, or the posterior lung surfaces. The small incisions used toaccess the posterior heart surface during the DEPA process acceleratesthe healing process and reduces the visible scar.

The invention contemplates use of any surgical device that may beadvanced through the access device to perform any procedure thatbenefits from or requires posterior visualization of organs as describedherein. The integrated vacuum coagulation probe embodiments inco-pending U.S. patent application Ser. No. 11/208,465, Ser. No.10/425,251, and U.S. Pat. No. 6,893,442 disclosed herein provideexamples of devices that allow intimate contact specifically between asoft tissue surface and the energy portion of the device. In thoseexample, the electrode(s) used to transmit energy (radiofrequency orultrasonic) is capable of heating the soft tissue until achievingirreversible injury making the soft tissue non-viable and unable topropagate electrical impulses, mutate, or reproduce. These integratedvacuum coagulation probe embodiments may be utilized during the DEPAprocess of the invention to coagulate soft tissue capable of treatingatrial fibrillation, ventricular tachycardia or other arrhythmiasubstrate, or eliminating cancer in lung, or other soft thoracic tissueby destroying target cells.

In addition, these integrated vacuum coagulation devices may be used toheat soft tissue along the posterior heart surface resulting inheat-induced contraction of collagen in such tissue thereby resultingshrinking of said soft tissue. For example, heating the mitral valveannulus along the posterior atrio-ventricular groove may induceshrinking of the annulus thereby correcting mitral valve regurgitation.However, it is understood that the invention is not limited to the abovedescribed vacuum coagulation probes. Instead, any number of coagulation,ablation, or surgical devices may be used as required.

The DEPA process and associated devices provide direct access to theposterior surface of the heart or lungs, or the esophagus, ascending ordescending aorta, pulmonary artery, or other soft tissue structure, andenable manipulation of tissue structures to complete the desiredsurgical procedure. For example, the DEPA process facilitates accessingand visualizing the posterior left and right atria when creating lesionsof structurally strong but electrically non-viable tissue along theatria to treat atrial fibrillation, atrial flutter, or othersupraventricular tachycardia, or along the ventricles to treatventricular tachycardia. In addition, such devices and methods couldsimplify and improve other soft tissue coagulation procedures byensuring direct visualization while precisely and effectively heating aregion of soft tissue. For example, ablation of cancer tissue in thelung or other anatomic structure is improved by the DEPA process anddevice embodiments of the invention. Similarly, the DEPA enablesinstrument manipulation and visualization for other cardiac (ornon-cardiac) procedures that required accessing the posterior heart (orposterior lung or other anatomy between the posterior heart/lungs andthe spine). For example, DEPA process will facilitate mitral valvecompression procedures that involve placing patches or other compressivemechanism along the posterior mitral valve annulus adjacent to theposterior commisseur that is commonly associated with deformation due toischemic injury or other cause of mitral regurgitation. For example,such treatment procedures as those described in pending U.S. applicationSer. No. 10/269,844 entitled “Systems for Heart Treatment” may benefitfrom the DEPA process and devices because it enables direct access tothe posterior surface of the heart and the target anatomic structures.

The DEPA process and device embodiments also enable reliable andcontrolled coagulation of soft tissue during less invasive procedures.Electrode(s) or antennas transmit energy (radiofrequency, directcurrent, ultrasonic, laser, infrared, or microwave) into tissue to causethe targeted soft tissue to heat thereby causing cellular responses thatresult in inhibiting conduction of electrical stimuli through the tissuecells but maintaining structural strength of the soft tissue.Alternatively, a cryogenic mechanism may be used to cool tissue belowthe isotherm of irreversible conduction block thereby rendering thetissue non-functional but structurally viable.

DEPA process embodiments and associated devices of the invention asapplied to treating atrial fibrillation are described as an augmentationto other surgical access or as a stand alone surgical access. The DEPAprocess and associated devices of the invention may be used to augmentother surgical access (e.g. thoracostomy, subxyphoid, mini-sternotomy,etc.) or may replace all other surgical access and provide the soleaccess for performing the surgical procedure.

Example of a Diaphragm Entry for Posterior Access (DEPA) AugmentingOther Surgical Access:

The example described below combines the DEPA process and associateddevices with conventional or modified thoracoscopic access to ensureoptimal visualization throughout the atrial fibrillation treatmentprocedure. It should be noted that the following description entails athorough description of a particular DEPA approach in using anembodiment of a coagulation probe as described above and incorporated byreference. However, the inventive method may involve fewer, additional,or variations of the detailed steps to perform any particular surgicalprocedure. Furthermore, the treatment may be applied with anyconventional device using any mode of treatment. Any such variationsfrom the steps described below are contemplated to be within the scopeof the invention.

In a standard procedure, the patient is prepared for the operation in astandard manner as described below:

The patient is taken to the operating room and placed in a supineposition with the arms adductive and flexed at the elbows to expose bothaxilla, as shown in FIG. 5A. The patient's legs may be placed instirrups similar to the technique described for Lap Nissenfundoplication, which allows the surgeon to stand between the patient'slegs and operate. However, this patient placement is an illustratedembodiment and not mandatory to the technique. The patient is positionedso that maximum exposure is obtained to the lateral aspects of the chestwall from the waistline to the axilla. This may be facilitated by use ofan operating table that narrows along the thoracic area to expose moreof the sides of the patient's thoracic cavity and enables rotation ofthe patient along the thoracic cavity. The patient's lower extremitiesmay be strapped across the waist and the legs within the stirrups toprovide security to the bed. The upper thorax, arms, neck, and head maybe secured to the bed to prevent the patient from slipping or slidingduring extreme Trendelenburg (to angle A) as shown in FIG. 5A andextreme rotation to the left and right. A specialized operating tablemay be configured to provide the restraint, freedom of movement (fromangle A (e.g. 30°) in FIG. 5A to angle B (e.g 30°) in FIG. 5B), andexposure described above.

The patient is intubated with an endotracheal tube; the bronchial lumenof the double lumen endotracheal tube is placed in the left main stembronchus to facilitate individual inflation/deflation of the right andleft lung lobes. Arterial monitoring is obtained via a radial artery anda Swan Ganz catheter is positioned via the right or left internaljugular for hemodynamic monitoring throughout the procedure. Atransesophageal echocardiogram is used to visualize the heart andinvestigate function and the presence of thrombus. The stomach isemptied by the nasal gastric tube, and a foley catheter is inserted todrain the bladder.

Next, the patient is shaved from the waist to the axilla, and from leftedge of the table to the right edge of the table. The patient is thenprepped and draped to expose the clavicle to the waistline and to bothsides of the bed for maximum exposure of the thorax, and abdominalcavity.

At this point, the left lung may be deflated by closing the endotrachealtube lumen feeding the left lung while the patient undergoes singleright lung ventilation.

As shown in FIGS. 5A and 5B, thoracoscopy is performed by making a smallincision 226 in the axillary line just beneath the left nipple at the7th intercostals space for placement of a thoracoscope. A 2nd incision228 is made anterior of the latissimus muscle in the mid-axillary linefor retraction. A 3rd incision 230 is made more inferiorly andposteriorly to the latissimus muscle in the mid-axillary line. Anadditional incision 232 may be necessary anteriorly along the 4th or 5thintercostals space beneath the left pectoralis muscle, perhaps in themammary crease. These incisions are placed after exposure of the heartis attained.

After placing the initial port and obtaining thoracostomy access, andallowing the left lung to deflate, attention is turned to the abdomenwhere various needles are used to insufflate the abdomen. After adequateinsufflation, a vertical skin incision 168 is made in the mid-lineapproximately 3 to 7 cm below the xyphoid process, on the abdomen sideof the diaphragm, as shown in FIG. 5D. This incision site issignificantly below (e.g. at least 3 to 7 cm below) any incision usedfor previously disclosed sternotomy, thoracotomy, or subxyphoid accessinto the thoracic cavity, all of which are located on the thoracic sideof the diaphragm.

The abdomen and its contents are visualized through the incisions. Asshown in FIG. 5D, an additional incision 172 is made approximately 5 mmin size beneath the right subcostal area with a 3rd incision 174 of theabdomen being made in the same area on the left subcostal area. Throughthese two incisions, the left lobe of the liver is liberated from thediaphragmatic surface. As shown in FIG. 5D, an additional 5 mm port 234is placed below the vertical incision to assist in retracting the lefthepatic of liver away from the mid-line diaphragmatic area. It should benoted that those incisions may alternatively be used for liverprocedures involving coagulating and/or resecting liver tissue toeliminate cancer or for other abdominal procedures involving coagulatingand/or resecting cancerous tissue.

Once the diaphragm is adequately exposed, the diaphragm is grasped onboth sides with Babcock clamps and a vertical incision is made in themid-line of the diaphragm 3 cm anterior to the crus. This incision isextended thru the diaphragm until the pericardium is identified. Itshould be noted that this incision places the operator directly beneaththe posterior surface of the heart providing direct access to theposterior atria. Once the pericardium is identified, it is grasped withendoscopic Babcock clamps and opened sharply with scissors. Thepericardium opening is then continued allowing pericardial fluid toclear into the abdomen; this fluid is aspirated with suction.

Next, the surgeon performs the DEPA procedure. As described above withregards to FIGS. 1A to 3F, the access device 182 is inserted through theabdomen and diaphragm and within the thoracic cavity. Creation of thetemporary cavity exposes the posterior surface of the organ (in thiscase, the heart).

Once adequate exposure to the posterior surface of the heart isobtained, attention is turned to the left pericardium where thepericardium is opened with forceps, and scissors thoracoscopicallythrough the left chest. A pericardial incision is made posteriorlybeneath the left phrenic nerve along the anterior border of the leftinferior pulmonary vein toward the superior pulmonary vein. Tractionsuture is placed in the pericardium and the pericardium is retractedanteriorly. A second retraction suture is placed posteriorly andretracted inferiorly to allow adequate exposure to the left inferiorpulmonary vein region. The anterior pericardium is divided toward theleft superior pulmonary vein to allow identification of the groovebetween the left superior pulmonary vein and the pulmonary artery. Itshould be noted that the pericardial incision can be made anterior tothe phrenic nerve and extended inferiorly along the border of thephrenic nerve or the phrenic nerve can be isolated and liberated betweenthe two incisions, one anterior and one posterior to the phrenic nerveleaving the phrenic nerve intact yet bridged between the diaphragm inletof the super-most portion of the phrenic nerve and the thorax.

The exposure of the left atrial appendage may be obtained via anincision anterior to the left phrenic nerve more superiorly upon thepericardium. After exposure to the left superior pulmonary vein isachieved, a right angle and sharp scissors are used to dissect thepulmonary vein and left upper lobe of the lung is liberated to allow theleft lung to fall into the left chest. Elevation of the patient inreversed Trendelenburg may assist in dropping the lung more inferiorlyallowing better exposure of the pulmonary veins in this area. Afteradequate dissection is performed, the right angle is passed over theleft superior pulmonary vein and is visualized with the diaphragmaccessed pericardial endoscope. Once the right angle is viewed with thediaphragm accessed scope, an umbilical tape (or vessel loop, or otheratraumatic elongate tether) is grasped using the pericardial graspingdevice through the separator/elevator central tube. This allowsattachment of the coagulation device to this umbilical tape (or vesselloop, or other atraumatic elongate tether). It also allows traction onthe pulmonary vein to position the coagulation device in a moreappropriate location along the pulmonary vein.

The coagulation device is then advanced from behind and inferior to theleft inferior pulmonary vein by attaching the device to the umbilicaltape to above the left superior pulmonary vein. The device is thenpulled and visualized with the DEPA scope to be in the appropriateposition behind the pulmonary veins. Once the coagulation device isappropriately positioned from inferior and posterior to the leftinferior pulmonary vein to the left superior pulmonary vein but in theposterior pericardium, the coagulation device is placed into contact(e.g. via vacuum application for the vacuum integrated devicesreferenced above) with the left atrium. This position is directly viewedwith the DEPA scope prior to transmitting the energy through thecoagulation device and into soft tissue.

The coagulation device is further retracted along the superior pulmonaryvein and anterior to complete the top of the superior pulmonary veincoagulation. Once visualization is verified by the DEPA scope, thecoagulation is performed. At this point, the completion of the pulmonaryvein isolation is performed by completing the anterior coagulation lineusing the thorascope to visualize the appropriate position of thecoagulation device and confirm tissue contact with the coagulationmechanism.

At this point, a coagulation line is created toward the left atrialappendage from the pulmonary vein coagulation lines taking care not todamage the phrenic nerve. This position is performed by directvisualization with the thorascope. Once this coagulation line iscompleted via the left thorax, attention is turned to the left atrialappendage.

An appendage grasper can be used to grasp the tip of the atrialappendage for retraction. FIGS. 16A to 16D show an example of anappendage grasper 200. The appendage closure mechanism, as shown inFIGS. 17A to 17C is applied under direct visualization from thethorascope. Staples 194, clips 196, clamp 198, sutures, or othermechanism may be applied to close the left atrial appendage 250. Ifstaples, clips, or sutures are used, pericardium may be incorporatedinto the closure site to prevent bleeding.

The umbilical tape is then repositioned across the top of the leftsuperior pulmonary vein and remains within the pericardium as far to theright as possible. The left lung is re-inflated leaving the umbilicaltape posterior towards the right superior pulmonary vein. The right lungis then allowed to deflate fully using similar thoracoscope ports andposition as the left, described above.

A right thoracoscopy is performed, as shown in FIG. 1A, and again thepericardium is liberated anteriorly to the phrenic nerve to allowexposure of the right inferior pulmonary vein, the space between theinferior vena cava and the right inferior pulmonary vein. The rightpulmonary vein is liberated from the pulmonary artery and the superiorportion right of the right superior pulmonary vein. Once this separationis visualized, the right angle is visualized to be within thepericardium by the DEPA scope. Again, umbilical tape is positioned inthis area and grasped by the DEPA grasping instrument. The umbilicaltape is placed towards the right inferior pulmonary vein. Thecoagulation device is positioned from inferiorly along the posteriorright pulmonary vein along the left atrium. Traction with the umbilicaltape assists with positioning the device posteriorly. Once thecoagulation device is positioned, it is actuated to coagulate a line ofsoft tissue. Again the right pulmonary veins are coagulated in a similarfashion to the left pulmonary veins described above, using assistance ofthe umbilical tape. The anterior line along the right pulmonary veins isperformed under direct visualization from the right thorascope.Additional exposure of the intra-atrial groove, separating the rightatrium from the pericardium, may provide better positioning of thecoagulation device. Once the device is positioned along the rightpulmonary veins, the coagulation device is activated and the rightpulmonary vein isolation is completed.

At this point, the umbilical tape that remained placed in the leftpulmonary veins is grasped from above the superior pulmonary veins usingthe DEPA scope to assist this position. The umbilical tape is pulledinto the right chest from the left chest and is attached to thecoagulation device. The coagulation device is positioned along theposterior left atrium. Positioning of the coagulation device isconducted under direct visualization from the DEPA scope. After positionis confirmed, the coagulation device is activated creating a line ofcoagulated tissue.

It should be noted that rotation of the patient left and right, as wellas Trendelenburg or reverse Trendelenburg may be beneficial toappropriately position the heart for maximum exposure of the DEPA scope.The access device 168 may require asymmetric expansion to further rotatethe heart relative to the patient, depending on the patient's body,anatomy orientation, and table configuration.

After creating all desired left atrial coagulation lines, thecoagulation device is positioned from behind the inferior vena cavausing the DEPA scope and along the anterior-most portion of right atriumand is connected to the right pulmonary vein isolation coagulation line.Once positioned, the coagulation device is activated. This coagulationline continues around the medial portion of the inferior vena cavatoward the coronary sinus. Coagulation is performed to theatrio-ventricular groove in this area with care to protect the rightcoronary artery. The coagulation is performed to the coronary sinustaking care to remain posterior to the coronary sinus and avoiding theAV node.

After creating the right atrial coagulation lines, attention is thenturned back to the left atrium, where a coagulation line is created fromthe inferior pulmonary vein to the coronary sinus towards the mitralvalve P3 leaflet. Care is taken to protect the coronary sinus andcircumflex once position is confirmed and coagulation activated.

FIG. 6A shows the completed coagulation line 191. After completion thecoagulation device is removed, the DEPA scope is removed, the expandablemember on the access device 168 compresses into a low profile allowingfor retraction of the access device 168. A smooth mesh patch (having awidth and length of approximately 3 cm×3 cm) is used to cover thediaphragm incision and is stapled or sutured to the diaphragm. Once thediaphragm incision is repaired, the left lobe of the liver is releasedand the abdomen deflated. Both lungs are fully inflated. If noparenchymal injury to the lungs is observed, no chest tube is necessary.If parenchymal injury is noted, chest tubes are placed bilaterally withHeimlich valves and the patient is returned to a more upright reversedTrendelenburg position and both lungs are reinflated with suction onboth catheters. Once this is performed, as long as there is not injuryto the lung, the chest tubes are removed on full ventilation byValsalva, to prevent air space in the left or right pleural spaces. Theincision in the abdomen is closed in two layers, as are the thorascopicincisions.

Example of a Stand Alone Diaphragm Entry for Posterior Access (DEPA):

This embodiment describes a stand alone DEPA process that does notrequire additional surgical access through the thoracic cavity, andassociated devices with during atrial fibrillation treatment procedures.Again, it should be noted that the following description entails athorough description of this particular DEPA approach using anembodiment of a coagulation probe as described above and incorporated byreference. However, the inventive method may involve fewer, additional,or variations of the detailed steps to perform any particular surgicalprocedure. Any such variations from the steps below are contemplated tobe within the scope of the invention.

As stated above, the patient is prepped and intubated. The endotrachealtube may enable individual inflation and deflation of lung lobes;however the stand alone DEPA process may not require deflation orretraction of lungs due to the access location which comes up throughthe diaphragm directly adjacent the posterior left atrium and leftventricle. Elimination of the need to deflate or retract the lungs (notattainable with conventional surgical approaches) will provide asubstantial benefit to patients by preventing lung damage and expeditingpatient recovery.

As stated above, hemodynamic monitoring is performed throughout theprocedure, and TEE is used to visualize the heart and investigatefunction and the presence of thrombus. The stomach is emptied by thenasal gastric tube, and a Foley catheter is inserted to drain thebladder. Various needles are inserted into the abdomen to insufflate theabdomen. After adequate insufflation, a vertical skin incision is madein the mid-line approximately 3 to 7 cm below the xyphoid process, onthe abdomen side of the diaphragm, as shown in FIG. 5D. This incisionsite is significantly below any incision used for previously describedsubxyphoid access into the thoracic cavity, which have been located onthe thoracic side of the diaphragm.

The abdomen and its contents are visualized through the incisions. Anadditional incision is made approximately 5 mm in size beneath the rightsubcostal area with a 3rd incision of the abdomen being made in the samearea on the left, as shown in FIG. 5D. Through these two incisions, theleft lobe of the liver is liberated from the diaphragmatic surface. Asshown in FIG. 5D, an additional 5 mm port is placed in the rightsubcostal area to retract the left hepatic of liver away from themid-line diaphragmatic area. Once the diaphragm is adequately exposed,the diaphragm is grasped on both sides with Babcock clamps and avertical incision is made in the mid-line of the diaphragm 3 cm anteriorto the crus, until the pericardium is identified. Once the pericardiumis identified, it is grasped with endoscopic clamps and opened.

Next, the surgeon performs the DEPA procedure. As described above withregards to FIGS. 1A to 3F, the access device 182 is inserted through theabdomen and diaphragm and within the thoracic cavity. Creation of thetemporary cavity exposes the posterior surface of the organ (in thiscase, the heart).

Once adequate exposure to the posterior surface of the heart isobtained, the pericardial reflections may be dissected at regions 224,if necessary, as shown in FIGS. 13A and 13B to free the pulmonary veins164 and/or inferior vena cava 202 to allow an access device 182 tofurther define the cavity between the posterior heart surface and thespine. A maneuverable dissector 124, as shown in FIGS. 13A, 13B, 14A and14B, may be used to dissect the pericardial reflections or otherinterconnective tissue or fat. This dissector can be steered remotely tochange the axis of the dissecting clamp relative to theseparator/elevator thereby facilitating access of target tissue locatedoff axis from the separator/elevator central lumen/opening. It should benoted that the central lumen 186 of the access device 182 mayalternatively comprise an elliptical cross-section, as shown herein,such that rigid instruments can be rotated off axis and access thepericardial reflections without the need for remote steering in thedissector.

It should also be noted that this posterior access through thepericardium obviates the need to manipulate or avoid the phrenic nerves,which run along the anterior heart surface. The pericardial incision ismade to fully expose the posterior left atrium and enable rotation ofthe heart via manipulation with the separator/elevator, rotating thepatient, placing the patient in Trendelenburg or reverse Trendelenburg,or other technique. Traction sutures may be placed in the pericardiumadjacent to the pericardial incision to further manipulate the heart.

After adequate dissection of the pericardial reflections is performed(if needed), a grasping device (e.g. clamp (deflectable or fixed), snare(deflectable or fixed), or preshaped clamp) is inserted through theseparator/elevator central lumen or opening and is passed along the leftpulmonary veins under direct visualization from the DEPA scope. Asilastic tube, an umbilical tape, or other atraumatic tensile member 248is advanced around the left pulmonary veins 164 using the graspingdevice 192, and is temporarily engaged to the coagulation device 2 toretract the coagulation device into position, as shown in FIG. 13C.

The coagulation device is then advanced partially or fully around theleft pulmonary veins by advancing the coagulation device and/orretracting the umbilical tape. The position and engagement of thecoagulation device is continuously visualized with the DEPA scope 184.Once the coagulation device is appropriately positioned partially orfully around the left pulmonary veins, the coagulation device is placedinto contact (e.g. via vacuum application for the vacuum integrateddevices referenced above) with the left atrium. This position isdirectly viewed with the DEPA scope prior to transmitting the energythrough the coagulation device and into soft tissue.

After creating the first coagulation line, the coagulation device isfurther retracted along the left pulmonary veins to complete theisolating coagulation line, as shown in FIG. 6B. Once visualization isverified by the DEPA scope, the coagulation is performed. At this point,the completion of the left pulmonary vein isolation is confirmed usingpacing techniques that demonstrate conduction block from the leftpulmonary veins to the rest of the atria.

A coagulation line is then created along the left atrial appendage fromthe left pulmonary vein coagulation line to the mitral valve annulus 206at the location where the great vein and circumflex have branched awayfrom the annulus exposing a segment of annulus along which no coronaryvessels run, as shown in FIG. 6B. This position is performed by directvisualization with the DEPA scope. Once this coagulation line iscompleted, the left atrial appendage is closed. The appendage grasper200, shown in FIGS. 16A to 16D is used to grasp the atrial appendage andthe atrial appendage is retracted. The appendage closure mechanism isapplied under direct visualization from the DEPA scope. Staples 194,clips 196, clamp 198, sutures, or other mechanism may be applied toclose the left atrial appendage, as shown in FIGS. 17A to 17C. Ifstaples, clips, or sutures are used, pericardium may be incorporatedinto the closure site to prevent bleeding.

The coagulation device is then repositioned around the right pulmonaryveins using the grasping mechanism described above and umbilical tape.It should be noted that the coagulation device may alternativelyincorporate a preformed shape or steering mechanism that facilitatesadvancing and deflecting the coagulation mechanism along the posterioratria. The coagulation device is positioned, under direct visualizationfrom the DEPA scope, around the right pulmonary veins and activated inserial steps that form lesion lines that intersect to form a completelesion absent of gaps at the intersection(s).

After creating the right pulmonary vein coagulation lines, thecoagulation device is positioned along the posterior left atrium 188 tointersect the left pulmonary vein and right pulmonary vein coagulationlines 191, as shown in FIG. 6B. Positioning of the coagulation device isagain conducted under direct visualization from the DEPA scope. Afterposition is confirmed, the coagulation device is activated creating aline of coagulated tissue.

It should be noted that rotation of the patient left and right, as wellas Trendelenburg or reverse Trendelenburg may be beneficial toappropriately position the heart for maximum exposure of the DEPA scope.The separator/elevator may also incorporate asymmetric expansion tofurther rotate the heart (side-side, head-toe, or other planarrelationship) relative to the patient, depending on the patient's body,anatomy orientation, and table configuration.

After creating all desired left atrial coagulation lines, thecoagulation device is manipulated through the working channel of theaccess device or opening under the inferior vena cava to create acoagulation line from the inferior vena cava to the tricuspid annulusunder the eustacian ridge. Once positioned, the coagulation device isactivated. Alternatively or in addition a coagulation line may beextended from the inferior vena cava 202 to the coronary sinus as shownin FIG. 6B taking care to remain posterior to the coronary sinus andavoiding the AV node.

Once all coagulation lines are completed, as shown in FIG. 6B, thecoagulation device is removed, the grasping instruments are removed, theDEPA scope is removed, and the access device is compressed into a lowprofile and retracted. A smooth mesh patch is used to cover thediaphragm incision and is stapled or sutured to the diaphragm.Alternatively, suture may be placed along the diaphragm to close thediaphragm incision without the need for a mesh patch. Once the diaphragmincision is repaired, the left lobe of the liver is released and theabdomen deflated. Since the lungs have not been deflated, parenchymalinjury to the lungs is avoided. The incision in the abdomen is closed intwo layers.

Example of an Esophageal Dissection.

Once a patient is identified and prepared for the procedure, a smallskin incision is made at the umbilicus and the abdomen is inflatedappropriately with a laparoscope. After obtaining adequate inflation, anendoscope is inserted and an additional abdominal port incision is madein the right subcostal area to retract the left lobe of the liversuperiorly to allow exposure of the esophageal hiatus. Two separateabdominal port incisions are made just inferior to the left and rightcostal margins to provide adequate mobilization and placement of thedissecting tools. The stomach and the gastric epiploic artery wascarefully protected and the short gastric was divided. The gastricepiploic is protected so the gastric epiploic artery can be identified.The short gastric is identified and freed toward the spleen using aHarmonic Scalpel. Once the stomach is completely liberated and the rightgastric epiploic artery is completely protected, the dissection iscontinued to the esophageal hiatus at the crus of the diaphragm.Attention is then turned to the first and second portion of the duodenumwhere dissection was performed laparoscopicly to mobilize the duodenumoff the right kidney. The stomach is further mobilized. The dissectionis extended toward the right crus of the diaphragm identifying the leftgastric artery. The left gastric artery is carefully divided usingendoscopic stapling and hemostasis is verified. The endoscopicpyloroplasty is performed using and endoscopic stapling device toapplicate the duodenum over the pyloric and an anatomosis is created toprevent gastric outlet obstruction.

At this point, using endoscopic Harmonic Scalpel, the esophagus isfurther liberated within the mediastinum. This dissection is continuedas far as one could see with the laparoscope and the Harmonic Scalpelthru the laparoscopic incision in the midline. The access device is thenplaced into the thoracic cavity and an endoscope is positioned throughthe access device and into the posterior mediastinum anterior to theesophagus. Using a dissector, the esophageal vessels are clearlyidentified. The vessels are then divided using a Harmonic Scalpel. Oncethe esophagus is liberated completely toward the mediastinum, the accessdevice is placed behind the esophagus and in singular fashion, thelateral esophageal vessels are divided from the esophagus. It ispreferable to visualize the esophagus to confirm that it is free of allattachments.

Examples of Lesions

It should be noted that any pattern of curvilinear, transmural lesionsmay be created along the epicardial surface or the endocardial surfacewith the coagulation devices using the DEPA process in conjunction withanother surgical access or as a stand alone process.

One potential left atrial lesion pattern involves creating a “C” thatpasses from the mitral valve annulus 206 adjacent the left atrialappendage (where the great vein and the circumflex do not parallel theatrioventricular annulus but have curved towards the apex of the leftventricle) above the superior pulmonary vein and back towards the mitralvalve annulus adjacent the right pulmonary veins; or below the inferiorpulmonary veins and towards the anterior mitral valve annulus. Anotherleft atrial lesion pattern involves creating a “V” where theintersection resides at the mitral valve annulus adjacent to the leftatrial appendage and each segment passes on opposite sides of thepulmonary veins and ends adjacent to the interatrial septum. A stretched“B” with each curved segment extending around either the left pulmonaryveins or the right pulmonary veins and the central links separated by adistance wherein the top line of the “B” connects to the mitral valveannulus adjacent the left atrial appendage may also be created.

As shown in FIG. 6C, a stretched “S”, reverse “S”, or figure eightcoagulation line 191 with the initiating point occurring at the mitralvalve annulus adjacent to the left atrial appendage and curving fromthat base point encompasses the left and right pulmonary veins as pairswithin the curved segments. As shown in FIG. 6D, two “C” lesions 191,one extending around the left pulmonary veins 164 and one extendingaround the right pulmonary veins 164, connect to the mitral valveannulus 206 and incorporate a flutter lesion extending from the inferiorvena cava 202 to the tricuspid annulus. In addition to the various leftatrial lesion patterns above, right atrial lesions may be created alongthe cristae terminalis, from the inferior vena cava to the superior venacava, from the cristae terminalis to the tricuspic annulus, from thesuperior vena cava to the tricuspid annulus, or other geometry capableof preventing atrial flutter along the right atrium.

Other Posterior Access Embodiments

FIG. 5C shows an alternative access that provides direct visualizationand manipulation of the posterior heart surface or lungs. The patient isplaced and restrained on his/her belly on the operating room table. Assuch, the patient's back is accessible by the surgeon. Gravity causesthe heart, lungs and other anatomy to move away from the back providingspace in which to access and manipulate instruments along the posteriorheart or lungs. Two back incisions 236 and 238 are created away from thespine and trocars are placed to access the thoracic cavity from theback. The trocars are located adjacent the spine and away from the aortaand esophagus to provide direct access to the posterior heart and lungs.

Separator/Elevator Embodiments

FIGS. 7A to 7C show an example of a novel access device 182 for creatinga temporary cavity within the body. FIGS. 7A to 7C show, respectively, atop view, a side-sectional view, and an end view of an alternativeaccess device 182. Generally, the device elevates organs and separatesadjacent organs or tissue surfaces to create a surgical area within thebody via creation of a temporary cavity. In the variation of FIGS. 7A to7C, the device 182 incorporates two expandable members 212. As describedherein, the device 182 may include any number of expandable members 212.However, regardless of the number used, the expandable members 212expand about the elongate member 210 (also referred to as a guide tube)to separate and elevate organs to create the temporary cavity.

In the variation shown in FIG. 7A, the expandable members comprise twoballoon bladders 212 (or a single balloon can be secured to the top andbottom of the elongate member 212 to define two bladders). The balloons212 are oriented along the two opposing sides of the elongate member210. When the balloons 212 inflate, as shown in FIGS. 7A and 7C, theyform a pillow-type support that fits around the spine and esophagus onone side and the heart on the other side. In this manner, the balloons212 serve not only to separate the organs, but also to stabilize them.It should be noted that the separation of the balloons on the elongatemember does not need to be symmetric, as shown in FIG. 7C but may bedifferent depending upon the particular application. For example, ashorter balloon can be used along the side of the device 182 thatcontacts the heart and a longer balloon can be used on the side of thedevice 182 that contacts the spine and esophagus, or vice-versa,depending on the patient anatomy. The balloons may be fabricated fromsilicone, urethane, polyester, PET, polyurethane, nylon, PEBAX, or otherpolymer capable of enlarging in response to being exposed to aninflation media. The guide tube 210 can be fabricated from any polymerand preferably has enough rigidity to provide column strength neededwhen inserting the access device into the space between organs (e.g.,the heart and the spine). For example, the guide tube can be fabricatedfrom polyurethane, PTFE, FEP, polyester, or other material that can beextruded or molded into the desired shape.

In variations of the access device 182, the expandable members (e.g.,balloons 212) expand in a non-uniform manner about the elongate member210. For example, as shown in FIG. 7C, the balloon 212 expand away fromthe sides of the elongate member 210 more than they expand away from thetop and bottom of the elongate member 210 This particular configurationpermits creation of the temporary cavity without moving the organs tofar from the opening 186 or slot 187 of the elongate member 210.Although variations of the access device 182 include expandable membersthat expand non-uniformly about the elongate member 210, the deviceincludes variations where the expandable member expands in a uniformmanner as well.

As shown in FIG. 7B, the elongate member 210 includes at least oneinflation lumen 214 that is fluidly coupled to the interior of one orboth balloons 212. Depending on the application, each balloon 212 mayhave an individual inflation lumen 214 to provide more control overinflation of the balloons and separation of the organs. The balloons maybe inflated using saline, CO2, or other biocompatible fluid. Theinflation lumens may be routed to the proximal end of the deviceincluding through ports in the handle. As discussed herein, theindividual balloons may be inflated to different pressures and/orvolumes such that one balloon provides more separation than the other.For example, when used against the heart, this mechanism causes theheart to rotate in one direction or the other providing a mode ofmanipulating the heart within the thoracic cavity. For example, thismanipulation allows instruments to better access the lateral surfaces ofthe heart, and/or even the anterior surface of the heart.

FIG. 7C illustrates the elongate member 210 including one or morevisualization elements 246. The visualization element may be an opticfiber, a CCD camera, a light source, etc. The optic fiber could be usedto transmit light and illuminate the cavity defined by the access device182. Alternatively, or in combination, the access device 182 mayincorporate near-field infrared transducers to identify blood vessels(veins and arteries) during use. By incorporating such near-fieldinfrared transducers, the surgeon can identify blood vessels (e.g. thepulmonary veins, coronary sinus, esophageal vessels, or other smallvessels while getting to the heart or separating the esophagus) andavoid them while dissecting or localizing them. Such near-field infraredtechnology can visualize vessels 2 mm under the surface of tissue.

As shown in FIGS. 7A to 7C, the device 182 includes a working channel211 that permits delivery of surgical tools and/or scopes to thetemporary cavity. This allows for creation of a surgical field at thetemporary cavity. The working channel 211 terminates at the opening 186at the distal end of the elongate member 210. Although FIGS. 7A to 7Cillustrate the opening 211 at a front face of the device 182, theopening 211 may be located at an end of the device 182 on a side asshown below.

The device 182 may also include a slot-type opening 187 on one or moresides of the elongate member 210. The slot 187 permits access to alarger portion of the organ within the temporary cavity. As shown, theends of the balloons 212 extend beyond the slot 187 improving theability of the device to form the temporary cavity. When the device isused against the heart, the slot provides access to the posterior heartsurface located within the contact region between the access device andthe heart. Without the slot 187, the access is only beyond the opening186 of the elongate member 210.

As shown in FIGS. 7A to 7C, variations of the access device 182 includeelongate members 210 having non-circular cross sections (e.g., oval asshown). The non-circular cross section of the working channel 211provides the ability to place multiple instruments through the accessdevice 182. To further increase the ability of the device 182 to handlemultiple tools, devices 182 of the present invention may be used withscopes having camera connections that are oriented at an angle (e.g.anywhere up to 90 degrees) from the scope shaft so the handles will notinterfere with the scope camera.

In the examples shown in FIGS. 7A and 7B, a planar surface 245 on oneside of the device 182 permits an increased surface area contact betweenthe device and tissue when creating the temporary cavity. This increasedsurface contact provides additional stability of the device 182 when inuse. Although, the expandable members 212 are shown to be placed onsides of the device 182 adjacent to the planar surface 245, additionalvariations of the device include expandable members on any surface/sideof the device 182.

As shown, a proximal end or proximal portion of the access device 182 isadapted to allow manipulation of the access device from outside of thebody. FIG. 7A illustrates proximal handles 256 that allow manipulationof the access device 182 and also prevents pushing the proximal end ofthe elongate member 210 or access device 182 completely into thepatient.

As shown in FIGS. 7B and 7C, a malleable or shapeable support 244 may beincorporated into the elongate member 210 to allow shaping the memberinto a desired configuration. The shape is selected to improve theability of the device to direct the scope and instruments towards thedesired site of a temporary cavity (e.g., posterior region of the heart,or other anatomic structure). The support 244 may be placed in a supportlumen such that the support 244 is slidable within the support lumen ofthe elongate member 210. Alternatively, or in combination, the elongatemember 210 may be fabricated from a shapeable material. Accordingly, theelongate member 210 could be shaped to a desired profile.

FIG. 7C also illustrates the access device 182 as having an optionalsuction or aspiration lumen 262. Because the device is suited forcreation of a temporary cavity to perform a surgical procedure underdirect visualization, it will be important to keep the scope or visualelement clear from bodily or other fluids. Accordingly, a suction devicemay be advanced through the working channel. Alternatively or incombination, a suction or aspiration lumen 262 may be placed within theelongate member 210.

FIGS. 7D to 7E illustrate another variation of an access device 182. Inthis variation, the elongate member 210 is tapered from the proximal endthe distal end. This tapering configuration allows the elongate member210 itself to separate tissue as the device 182 advances to a targetsite. FIG. 7E illustrates a perspective profile of the tapered elongatemember 210 (showing the various inflation and/or aspiration lumens).Again, the cross-sectional profile of the working channel 211 may be anygeometric shape. However, shapes in which working channel width is notequal to the working channel height may be preferred (e.g., rectangular,oval, trapezoidal, etc.). FIG. 7C also demonstrates a variation of adevice 182 where the expandable members 212 surround the distal end ofthe elongate member 210. This variation creates a space between theelongate member 210 and the organ.

FIGS. 7F to 7I illustrate additional variations of access devices 182.As shown in FIG. 7F, the access device 182 may include an additionalworking lumen 272 within the elongate member 210. The additional workinglumen 272 in this variation is separate from the working channel 211 andprovides an access channel that permits the ability to leave a device atthe temporary cavity while advancing and/or removing other deviceswithout causing undue interference between devices. For example, theadditional working lumen 272 may be used to advance a scope-type deviceto the temporary cavity. In this manner, the scope-type device may beleft in the working lumen 272 while other devices are inserted andmanipulated in the working channel 211. This reduces the chance that thescope is disturbed.

FIG. 7G illustrates a front view of the access device 182 of FIG. 7F. Asshown, the access device 182 includes a working channel 211, anadditional working lumen 272, an inflation lumen 258 coupled to theexpandable members 212 and an aspiration lumen 252. In one variation,the multi-lumen access device 182 may be fabricated from a plurality oftubes having a covering or coating that defines the outer surface of theelongate member 210. As illustrated, the device 182 may include multipleexpandable members 212 located at a distal end.

FIG. 7H illustrates another variation of an multi-lumen access device182. As shown, the access device 182 may comprise an elongate member 210having a passage to serve as the working channel 211. Separate tubes orsimilar structures may be placed within the working channel 211 to forma working lumen 272, aspiration 252, and inflation lumen 258. Theselumens may also be formed using an extruded multi-lumen elongate member210. FIG. 7I illustrates a rear view of the access device 182 of FIG.7H. As shown, the expandable members 212 may be formed from a singleballoon bladder located about the distal end of the device 182.

FIG. 7J show a variation of an access device 182 where the workingchannel 211 and second working lumen 272 are offset or staggered at theproximal end of the device 182. This configuration reduces interferencebetween devices at the user end of the access device 182. Furthermore,the proximal end of the working channel 211 may be tapered along an endof the elongate member (as shown) to increase the area through whichinstrumentation enters the working channel 211.

FIGS. 8A to 8C show respective top, side, and bottom views of an accessdevice 182 as described herein having both an expandable member 212 andseparate stabilizers strands 216. As shown, the expandable membercomprises a balloon 212 affixed to the elongate member 210 or guidetube. In this variation, the elongate member 210 has a non-circularcross-section defining a working channel 211 (e.g. elliptical,rectangular as shown, trapezoidal, or any other geometric shape). Theworking channel 211 allows for access to the temporary artificial cavityformed by the device. The elongate member 210 may be shapeable or have aparticular curve as discussed herein. As noted above, in thosevariations where the guide tube maintains a curve, the curve will beselected depending on the desired surgical application. For example, todirect access from the skin incision/puncture on the abdominal side ofthe diaphragm, under the diaphragm and towards the posterior surface ofthe heart the access device 182 may have a distal portion that is curvedor angled as shown in FIG. 8B.

In the variation shown in FIGS. 8A to 8C, the balloon is affixed along aplanar side of the elongate member 210 such that the sides and bottom ofthe balloon are free and not attached. This configuration allows theballoon 212 to adjust to the spine, esophagus, and other structureswhile separating the heart with the stabilizer side of the elongatemember 210. The stabilizer strands 216 may be fabricated to be malleableso that they fit around an organ and stabilize the organ during theprocedure. For example, when used against the heart, the strandsstabilize the heart as the balloon inflates to create the temporarycavity. The stabilizers 216 support the heart during manipulations ofthe instruments along the posterior surface of the heart or within theartificial cavity defined by the access device 182.

The stabilizer strands 216 are preferably fabricated from the elongatemember 210 by cutting slots and preshaping the stabilizing features.However, the stabilizer may alternatively be fabricated from anothercomponent (e.g. spring metal such as spring steel or nitinol) coveredwith an atraumatic polymer and secured to the guide tube.

FIGS. 9A and 9B show an alternative access device 182 that incorporatesexpandable members comprising enlargeable strands 216 or stabilizers.The strands 216 may be preformed strands 216 or stabilizers fabricatedfrom a spring material (e.g. a flexible polymer, spring stainless steel,nickel titanium, or other metal treated to meet the elastic requirementsof the device). In some variations, the strands 216 assume a preshapedconfiguration upon deployment of the device. The strands 216 can bedeformed during deployment to nest or separate the appropriate organ.The strands 216 may be malleable or resilient. For elastic or resilientstrand configurations, the strands 216 have an expanded preshapedorientation. Wires may be used to retract the strands into a lowprofile. Once positioned, the wires may release the strands such thatthey expand radially outward into contact with the anatomy. Invariations where the device is used to separate the heart from theesophagus, once both sets of strands are advanced, the strands separatethe heart from the spine and esophagus, providing a temporary cavity inwhich instruments can be inserted and scopes can provide directvisualization, (e.g., as shown in FIGS. 3A to 3C).

In alternate variations, the strands 216 are actuated into an enlargedconfiguration upon positioning of the device. In the variation shown inFIG. 9B, the strands 216 can be actuated to cause advancement orretraction of the strands. As shown, one end of the strand may beaffixed to the elongate member 210, while the other end may beadvanceable within the elongate member. It should be noted that thestrands may be individually enlarged to permit selective separation ofthe heart thereby lifting one side of the heart and rotating the heartto access the lateral surfaces and even the anterior surface of theheart. Furthermore, the strands 216 may be of different sizes as shownin FIG. 9A where the strands on the top of the device have a smallerexpanded profile than the strands on the lower portion of the device.

In most variations, the stabilizing strands 216 designed to beatraumatic. For example, there may be a covering that prevents abradingor cutting of the anatomy that is separated by the strand 216. The spacebetween the two sets of strands can be set based on the anatomic and/orprocedure requirements.

FIGS. 9C and 9D show another variation of an access device 182comprising a balloon 212 surrounding two expandable strands 216. Itshould be noted that any number of expandable strands may be used. Theballoon 212, in this configuration, is attached to the strands anddefines a free balloon along the side opposite to the strands. As such,when the strands 216 expand they enlarge the balloon and contact thespine region to provide a stabilizing point. As the balloon inflatesusing inflation media delivered through the inflation lumen 214, theballoon also surrounds the organ being separated. This function providesan atraumatic surface while separating and stabilizing the organs. Forexample, as the balloon inflates to separate the heart from adjacentorgans, inflation of the balloon forms an atraumatic surface to supportthe heart. It should be noted that this variation of the device 182 mayalso be used when rotated 180 degrees so the expandable strands supportthe heart and the free side of the balloon contacts the spine andesophagus. The balloon is attached to the guide tube distal and proximalto the strands to define a fluid impervious bond. It should be notedthat the two strands may be individually actuated to permit selectiveseparation of the heart thereby lifting one side of the heart androtating the heart to access the lateral surfaces and even the anteriorsurface of the heart.

FIGS. 10A to 10C show an alternative variation of an access 182 where anexpandable member comprises two sets of enlargeable strands 216, one setlocated towards a distal end of the device and a second set locatedproximally on the elongate member 210. The strands 216 may operate inany manner as described above. Variations of the device include sets ofstrands 216 that are offset either axially or radially from each other.

FIGS. 11A and 11B show an end portion of an access device 182 thatcomprises a series of enlargeable strands 216 along two sides of theelliptical elongate member 210. FIG. 11B shows the strands 216 in acompressed, low profile configuration. FIGS. 11C and 11D show a side andfront view respectively of the access device 182 of FIGS. 11A and 11B.As shown, the strands are in an enlarged, expanded configuration. Again,the strands can be expanded as described above and define stabilizingsurfaces to support the adjacent organs that are separated to producethe temporary cavity.

FIGS. 12A to 12C show another variation of an access device 182. In thisvariation, the device 182 incorporates three balloons 212 where twoballoons 212 are oriented along the top of the elongate member 210 and asingle balloon 212 is located at the bottom of the elongated 210. Asshown, the balloons 212 may have pre-determined shapes that are usefulwhen performing various procedures. For example, the bottom balloon 212has a semi-circular groove on a surface that is opposite to the elongatemember. This groove permits nesting of various organs (e.g., the spineor the esophagus) when creating the temporary cavity.

FIGS. 12D to 12F illustrate another variation of an access device 182.In this variation, the balloons 212 are selected to have a rectangularcross section when viewed co-axially along the elongate member 210 (asshown in FIG. 12D). Balloon 212 for use with the present device 182 mayhave any type of cross-section. As described below, the balloons mayhave varying shapes to accommodate certain organs or to create clearanceat the opening 186 of the device 182. Such balloons may be pre-formed toa specific shape or cross-section. Furthermore, non-distensible balloonsmay also be employed with variations of the device.

FIG. 12D also shows the distal end of the elongate member 210 as beingcurved or angled to allow for a larger opening 186. Such a configurationpermits greater access to the surface of the organ adjacent to thetemporary cavity. As discussed above, the elongate member 210 mayfurther include a plurality of aspiration/suction ports 262 located atan end of the device.

FIG. 12F illustrates yet another variation of an access device 182 wherea length of one balloon member 212 is greater than the length of asecond balloon member 212. Such a difference in length may be selecteddepending upon the desired procedure. In an alternate variation, asingle balloon 212 may be employed where a portion of the balloon on oneside of the elongate member 210 is shorter/longer than a portion of thesame balloon on another side of the elongate member 210.

FIG. 12G shows a variation of an access device 182 where at least aportion of the balloon members 212 extend beyond the opening 186 of theelongate member 210. This configuration assists in spacing tissue fromthe opening 186 and reduces the probability that the tissue wouldotherwise obscure the visualization element (e.g., an endoscope) withinthe working channel 211 of the device 182. As shown, the device 182 mayfurther include suction or aspiration ports 262 within the workingchannel 211 of the device and adjacent to the opening 186.

FIG. 12H illustrates a variation of an access device 182 in which theprofile of the balloons 212 allows for clearance around the opening 186of the working channel 211. Accordingly, a length of the balloon 212adjacent to the elongate member 210 is less than a length of the balloon212 at a surface away from the elongate member 212. FIG. 12H also showsa variation of the access device 182 as having locking members orballoons 264. The locking balloons 265 may be spaced from the distal endof the device 182 sufficiently so that upon inflation, they secure thedevice at the site by expanding within the body or outside of the bodyat the site of the incision. FIG. 12J shows a front view of the accessdevice 182 of FIG. 12H. As shown, the end of the device 182 may includea suction/aspiration port 262 and a visualization/illumination element246 that are spaced away from surrounding tissue due to the constructionof the balloon 212.

FIG. 12J illustrates another variation of an access device 182 where theballoon members 212 are axially spaced along the elongate member 210.

FIGS. 18A to 18C illustrates a variation of an access device 182 havingan expandable member 266 that is slidable within the working channel 211of the elongate member 210. As the expandable member 266 advances out ofthe elongate member 210, the expandable member expands in a manner thatelevates and separates organs. As shown, the expandable member of FIG.18A comprises a first and second set 268, 270 of arms. In thisvariation, the sets of arms 268, 270 expand in a non-uniform mannerabout the elongate 210 member. FIG. 18B shows a side view of the accessdevice of FIG. 18A when the first and second set 268, 270 of the armsextends from the elongate member. FIG. 18C shows the first and secondset 268, 270 of arms retracted within the elongate member 210.

FIGS. 19A to 19B illustrate a variation of the access device 182 similarto the one shown in FIGS. 18A to 18C. However, in this variation, theaccess device 182 includes a first and second set 268, 270 of armswithout spacing between the individual arms.

FIGS. 20A to 20B illustrate yet another variation of an access device182. As shown in FIG. 20A, an access device 182 may also be used inparts of the body apart from the DEPA process. In this variation, theaccess device 182 has a curved shape to assist in positioning of thedevice 182 when advanced directly into the chest cavity during, forexample, a sub-xyphoid approach as opposed to through the diaphragm 170.The shape of the access device 182 will vary depending on the procedureand intended entry procedure. As shown in FIG. 20B, once positioned, theexpandable members 212 of the access device 182 may be inflated toelevate and separate organs to form a temporary cavity. Accordingly,variations of the present access devices 182 include elongate membersthat are curved, shapeable, or flexible to accommodate placement throughthe traditional entry techniques mentioned above.

FIG. 21A shows additional features for use with access devices describedherein. The illustration shows an access device 182 having an expandablemember at a distal end of an elongate member 210. As shown, the elongatemember may have a reinforcing member 282 extending over all or a portionof the elongate member 210. While the illustrated reinforcing member 282is external to the elongate member 210, it may be located interior to,exterior to, or within the walls of the elongate member 210. Thereinforcing member 282 may be a braided support, a coiled support, amesh support or any such type of support that reinforces the elongatemember 210. Although not illustrated, the access device 182 mayoptionally have any number of handles, or other features that allowmanipulation of the device.

FIG. 21A also shows a rail-member 282 extending through the accessmember 182. The rail-member 282 can be a coiled guide-wire, anatraumatic guide-wire, polymeric strand or tube, or any similarstructure. In use, the rail-member 282 has a portion that is affixedrelative to the elongate member 282 and an axially moveable portion thatextends within the elongate member 210. In most cases, the rail-membershould not cause trauma to the intended region of tissue. For example,if use near cardiac tissue, the rail-member should be of a sufficientdiameter so that it does not inadvertently cut or damage cardiac tissue.

Typically, the far portion 284 of the rail-member 282 is affixed towithin the elongate member 210 so that distal movement of the remainingportion of the rail-member 282 causes an intermediary or mid-portion ofthe rail-member 282 to assume an arcuate profile, shape or perimeter(hereafter referred to as an arcuate profile) 288. In this variation,the shape formed is a semi-circular open-ended profile. However, therail-member 282 can be fabricated to form any number of shapes. Forexample, the entire rail-member or a portion of the rail-member may havea pre-determined profile such that advancement of the rail-member out ofthe access device 182 causes the rail-member to assume the profile. Inaddition, the profile may be any geometric shape desired.

In the variation shown, the rail-member 282 is affixed to an inflationlumen 214 of the elongate member 210. However, the rail-member 282 maybe affixed anywhere within or outside of the elongate member 210.Furthermore, while the rail-member 282 is shown as extending through theelongate member 210, additional variations include rail-membersextending exterior to (or partially exterior to) the elongate member210.

FIG. 21A also illustrates the access device 182 as having a valve 290.In one variation, the valve 290 may be a duck-bill valve that partiallyextends within the working lumen of the elongate member 210. Such avalve closes around the item being passed through the working channel.However, any type of valve can be used depending on the desiredapplication.

FIG. 21B illustrates a cross sectional view of the access device 182 ofFIG. 21A. As shown, the rail-member 282 extends through the workingchannel 211 and through a valve 290 (in this case a duckbill valve) atthe proximal end of the elongate member 210. Generally, the rail-member282 is fabricated from a material such as a shape-memory alloy, asuper-elastic alloy, metal alloy, polymer, or polymeric blend ofmaterials. In most cases, the rail-member 282 is intended to function asa rail for the advancement of various medical implements. As such,variations of the rail-member 282 may be constructed to have sufficientstiffness so that the profile of the mid-section 288 stays substantiallywithin a single plane. Naturally, the orientation of the mid-section may288 can be manipulated by movement of the proximal or near end of therail-member.

FIG. 21C shows a top view of the access device 182 of FIG. 21A. Asdiscussed above, access devices 182 according to the present inventionmay include one or more slots 187 adjacent to the opening 186 at thedistal end of the elongate member 210. This slot 187 has beenparticularly useful to manipulate/rotate instruments within the workingchannel 211. In the variation shown, the expandable member 212 is formedround the slot 187 so that upon expansion, the expandable member 212does not occlude the temporary cavity space that is adjacent to the slot187.

FIG. 22A shows an example of the rail-member 282 in use. For purposes ofillustration, the expandable member 212 is not shown in an inflatedposition. During use of the device, the expandable 212 member may befully or partially expanded. Alternatively, the expandable member 212need not be expanded during use. As shown, the mid-section 288 of therail-member 282 remains within the device 182. Also, in thisillustration, the far end of the rail-member 282 is affixed within theworking channel 211 of the access device 182.

FIG. 22B illustrates axial movement of the rail-member 282, particularlydistal movement of the near end 286 of the rail member 282. As therail-member 282 advances, the mid-section 288 assumes an arcuateprofile. As illustrated, the profile of the mid section 288 is shown tobe an open-ended loop. However, any number of shapes are contemplated tobe within the scope of this invention.

FIG. 22C shows the advancement of a treatment device 300 over the railmember 282. The treatment device 300 will include a rail-lumen or trackallowing for the device 300 to advance along the rail-member 282 andultimately take the shape of the profile of the mid-section 288.Although not limited to the pictured illustration, the treatment device300 can include an electrode 302 for treatment of tissue. As shown, theelectrode 302 may optionally also take the shape of the mid section 288.In use, the rail-member 282 is advanced out of the access device 182while over the tissue to be treated. The rail-member 282 provides theability of the medical practitioner to position treatment devices 300with greater precision. The access device 182 with rail-member has alsoshown considerable promise in positioning treatment devices 182 overposterior regions of organs in the thoracic cavity as described herein.

FIG. 23A illustrates another variation of an access device 182 asdiscussed above having handles 256 with the addition of a rail-member.In this variation, the rail-member 282 expands substantially distally tothe opening 186 of the access device 182. FIG. 23B illustrates anothervariation of an access device 182 according to the present invention. Inthis variation, the access device 182 may include an additional workinglumen 272 within the elongate member 210. The additional working lumen272 in this variation is separate from the working channel 211 andprovides an access channel having the ability to leave a device at thetemporary cavity while advancing and/or removing other devices withoutcausing undue interference between devices. In this variation, the railmember 282 is affixed within the working channel 211 of the device.However, the rail-member 282 may also be affixed to the additionalworking lumen 272.

The rail-member 282 may be a separate or separable from the body of theaccess device 182 and temporarily affixed into a lumen or receptacle inthe access device 182 to provide a rail-type function over whichtreatment device can be advanced. This separate/separable featurepermits use of a single rail-member that can be inserted into theworking channel 211 of the access device 182 and can be used to guidethe treatment devices to their intended location. In addition, theelongate member 210 of the access device 182 can incorporate one or moremultiple lumens through which the rail member 282 can be advanced.

As shown in FIG. 23C, variations of the access device 182 may have oneor more opening 292 to temporarily or permanently attach or advance arail-member 282 The device 182 may have openings, apertures, notches orother such features in place of openings 292. Regardless, such openings292 or other features that allows the user to change the location of therail-member on or within the elongate member 211. In one example, suchfeatures allow for the user to change the shape of the loops created bythe rail-member or to otherwise manipulate the rail-member relative tothe access device 182. For example, in the example shown in FIG. 23C,the rail-member 282 expands in profile on the right side of the accessdevice 282. However, by extending the rail-member 282 from or throughanother opening 282, the user can select how the rail-member 282 expandsin profile.

FIGS. 24A-24C illustrate the access devices 182, as described herein,when used in video assisted procedures such as pericardiac surgery ortrans-abdominal pericardiac surgery. As noted previously, the accessdevices described herein allow for direct visualization and exposure tothe posterior surface of organs within the thoracic cavity. Theillustrated examples demonstrate how the access devices enable access toposterior regions of the heart for the creation of exterior Mazelesions. The use of the access device 182 also optionally allows asurgeon to create such lesions without dissection of the pericardialreflections (a line of folding along which the visceral pericardiumbecomes the parietal pericardium). This ability to create lesionswithout dissection of this tissue enables a faster procedure as well asimproved recovery time. However, these devices may also have widerapplications and, unless otherwise indicated, their uses are not limitedto any particular type of surgery.

As shown, in FIG. 24A, a surgeon advances a guidewire or rail-member 282to (or near) the intended treatment site. As shown, the rail-member 282may be advanced by itself and subsequently joined with the access device182. The placement of the rail-member 282 may rely on one or moreadditional guide-wires. Furthermore, the rail-member may have a floppydistal end (or both ends may be floppy.) As the distal end is placedalong or near the target tissue, it may be fed into the access device182. A treatment device, such as a coagulation device, can then be fedover the rail-member to apply the desired treatment.

In one example, when treating the heart, a surgeon may placing aguidewire that functions as the rail-member through an access location(port, incision, etc.), along the roof of the left atriaum (afterdissecting the superior vena cava, the aorta, and the pulmonary artery).Next, the surgeon advances the guide-wire along the anterior surface ofthe left pulmonary vein and into the access device. A coagulation devicecan then be fed over the guidewire to create the roof lesion and ananterior pulmonary vein lesion. The same or similar techniques may beused when placing the guidewire along the anterior right pulmonary veinto create right atrial or other lesions.

FIG. 24B illustrates advancement of an access device 182. Variations ofthe procedure include first advancing the access device 182 andpositioning the access device (the expandable members may or may not beexpanded) then advancing the the rail-member through the access device.Once the rail-member is in a desired location, it may then be affixed orjoined to the access device. Alternatively, the rail-member 282 may bepositioned and then the access device can be positioned over therail-member 282 at or near the target site. Ultimately, the rail-member282 is affixed or joined to the access device 182. It will be apparentto those skilled in the art, that a medical practitoner may use surgicalmanipulation instruments to affix or join the rail-member 282 to theaccess device 182 when both are within the body.

FIG. 24C illustrates the rail-member 282 after affixing or joining withthe access device 182. As noted above, once coupled to the access device182, an end of the rail-member 282 can be manipulated by the medicalpractitioner to assume a profile or shape suited for guiding a treatmentdevice. In some cases, the rail-member 282 itself may actually be usedto grasp or cut tissue. However, in most variations, the edges of therail-member are selected so as to be atraumatic to tissue as the medicalpractitioner positions the rail-member 282 within the body.

FIG. 24C also shows a treatment device 300 advanced over the rail-member282. The rail-member 282 and/or treatment device 300 may then bemanipulated to positioning the treatment device 300 over or on thetissue to create the desired lesion or treatment pattern.

Although the access devices described above are not limited in thedevices that are advanced over the rail-member, it was found thatablation catheters having suction capabilities allowed for improvedcontact between the electrode and tissue being coagulated. In addition,it was found useful to include a lubricious material (such as apolyimide tube) when advancing the coagulation devices over therail-member. In addition, such devices were constructed to havesignificant stiffness and torque characteristics to aid in manipulationof the devices at the target region.

Examples of such probes are disclosed in: U.S. patent application No. tobe determined and filed on the same day as this application, entitled“Vacuum Coagulation Probes”, (Attorney Docket No. NCNT-N-Z009.00-US);U.S. patent application Ser. No. 11/408,302 entitled “Vacuum CoagulationProbes”; U.S. patent application Ser. No. 11/208,465 entitled “VacuumCoagulation & Dissection Probes”; U.S. patent application Ser. No.10/425,251 entitled “Vacuum Coagulation Probes”; U.S. Provisionalapplication No. 60/726,342 entitled Diaphragm Entry for Posterior AccessSurgical Procedures; and U.S. Pat. No. 6,893,442 the entirety of each ofwhich is hereby incorporated by reference.

FIG. 25 illustrates one example of lesion patterns 191 created on aposterior surface of the heart using the access device and probesreferenced herein. These lesion patterns 191 avoid the need to dissectpericardial reflections from the pulmonary veins because the devicesallow for creating lesions along the pericardial reflections rather thanthrough them.

Dissecting/Tunneling Embodiments

FIGS. 13A and 13B show the advantages of the DEPA process and associateddissecting/tunneling tool 124 device embodiments that provide directvisualization and exposure to the pericardial reflection in order thatare designed to remove or separate adipose tissue (e.g. fat) and/orinterconnective tissue from the heart to expose muscle layers and permitmaneuvering the coagulation device or other instrumentation intoengagement with heart tissue at any location, whether or not previouslycovered by fat or interconnective tissue.

FIGS. 14A to 14D show two side views and two cross-sectional views (atlines A-A and B-B respectively) of a dissecting/tunneling tool 124embodiment capable of separating fat tissue. A shaft 98 supports twoflexing segments 96, one at the proximal end adjacent to the handle 102and the other at the distal end adjacent the dissecting legs 72. Fourpull-wires 76 oriented at 90 degree intervals around a central axis aredeflected by the handle and movement of the handle relative to the shaftat the proximal flex region 96 to cause the distal dissecting segment tocorrespondingly pivot at the distal flex region 96. As the shaft 98 isadvanced the distal leg actuation 142 is advanced over the legs 72 tocause the legs to close and is retracted to urge the legs to open.

FIGS. 14E to 14G and 15A to 15D show alternative leg 72 and distalpivoting 96 configurations for various dissecting/tunneling instrument124 embodiments.

Appendage Grasper/Positioner

FIGS. 16A to 16D show an appendage grasper 200 that stabilizes theatrial appendage and repositions the atrial appendage during thecoagulation process and/or appendage isolation process. The appendagegrasper 200 incorporates a vacuum lumen 6 that is coupled to a vacuumopening 28 in the covering 7 that defines an opening 20 that appliessuction to the atrial appendage and pulls the atrial appendage intoengagement with the grasper during manipulation of the atrial appendage.

Appendage Closure

FIGS. 17A to 17C show an appendage 250 that is closed with staples 194,snaps 196 or a clamp 198 during a DEPA process where diaphragm access tothe posterior heart surface provides additional visualization of theleft or right atrial appendage while closing the atrial appendage fromthe outside surface of the atrium. As described above, theseparator/elevator may incorporate individually adjustable enlargementmechanisms (e.g. bladders or strands) to enable rotating the heart whichprovides additional access to the lateral surface of the heart.Augmenting this with thoracic access to the left atrial appendageenables grasping the appendage (e.g. with the grasper 200) and applyingstaples 194, snaps 196, a clamp 198, or other mechanism capable ofclosing the orifice of the atrial appendage and preventing blood insidethe atrial appendage from communicating with (e.g. flowing into) therest of the atrium.

Diaphragm Patch

A diaphragm patch measuring approximately 3 cm×3 cm may be used to closethe diaphragm incision after the DEPA procedure has been completed andthe incisions are to be closed. The patch may be fabricated fromexpanded PTFE, woven polyester, or other atraumatic polymer capable ofbeing sewn or staples to the diaphragm such that when the entirecircumference is sewn or staples, a fluid impervious surface is createdalong the DEPA incision through the diaphragm. The patch may alsoincorporate pledgeted outer surface to facilitate sewing and/or staplingand prevent bleeding during the patching step of the procedure.

Although the present inventions have been described in terms of thepreferred embodiments above, numerous modifications and/or additions tothe above-described preferred embodiments would be readily apparent toone skilled in the art. It is intended that the scope of the presentinventions extend to all such modifications and/or additions and thatthe scope of the present inventions is limited solely by the claims ofthe invention.

Various kits can be sold that provide the practitioner with a completesystem with which to perform a DEPA procedure. A separator/elevator, acoagulation device, an endoscope, a dissecting/tunneling instrument,trocars, a diaphragm patch, and staples to close the diaphragm openingmay be incorporated into a kit used for atrial fibrillation orventricular tachycardia treatment using a DEPA procedure.

1. An access device for creating a temporary cavity between organs in abody, the access device comprising: an elongate member having a workingchannel extending therethrough, the elongate member having a distalportion adapted for insertion into the body and a proximal portion, theelongate member having a column strength to allow insertion of thedistal portion between organs; and a slot shaped opening at a distal endof the elongate member, where the working channel exits the elongatemember at the slot shaped opening comprising a slotted portion extendingalong a wall of the elongate member. 2.-4. (canceled)
 5. The accessdevice of claim 1, where the elongate member further comprises a secondworking lumen extending therethrough, the second working lumen beingseparate from the working channel and, where the working lumen exits theelongate member at a separate opening.
 6. The access device of claim 5,where at the proximal portion of the elongate member, the workingchannel and second working lumen are staggered.
 7. The access device ofclaim 1, where at the working lumen is smaller in size than the workingchannel.
 8. The access device of claim 1, where at the working lumen isthe same size as the working channel.
 9. (canceled)
 10. The accessdevice of claim 1, further comprising a braided support member along thedistal portion of the elongate member.
 11. The access device of claim 1,where the braided support member is located within a wall of theelongate member.
 12. The access device of claim 1, further comprising avalve in fluid communication with the working lumen.
 13. The accessdevice of claim 12, where the valve is located over a proximal openingof the elongate member.
 14. The access device of claim 1, where theproximal portion of the elongate member is adapted to allow manipulationof the access device outside of the body.
 15. The access device of claim14, where the proximal portion of the elongate member comprises a handlethat allows for manipulation of the access device.
 16. The access deviceof claim 1, where the elongate member is tapered towards the distalportion.
 17. The access device of claim 1, where at the proximalportion, the working channel is tapered along a proximal end of theelongate member to increase an area through which instrumentation entersthe working channel.
 18. The access device of claim 1, where a length ofthe elongate member from a proximal end to the slot shaped opening is 30cm.
 19. The access device of claim 1, further comprising a shapeablesupport member located elongate member, where the shapeable supportmember causes the elongated member to retain a shape of the shapeablesupport member.
 20. The access device of claim 19, where the elongatedmember further comprises a support lumen and where the shapeable supportmember is slidably located within the support lumen. 21.-22. (canceled)23. The access device of claim 1, where the elongate member furthercomprises at least a first inflation lumen therein, and where the firstexpandable member comprises a first balloon having an interior in fluidcommunication with the inflation lumen, where the first balloon isadapted to inflate to separate the body organs. 24.-36. (canceled) 37.The access device of claim 23, where the elongate member comprises ashapeable material.
 38. The access device of claim 23, where the distalportion of the member is curved or angled.
 39. The access device ofclaim 23, where the elongate member further comprises at least onesuction lumen located in a wall thereof, and where the suction lumenterminates in a suction port located at the distal end of the elongatelumen.
 40. The access device of claim 23, where the elongate memberfurther comprises at least one suction lumen located in the workingchannel, and where the suction lumen terminates in a suction portlocated at the distal end of the working channel.
 41. The access deviceof claim 1, further comprising at least one visual element located in adistal portion of the elongate member.
 42. The access device of claim25, where the visual element is a fiber optic scope.
 43. The accessdevice of claim 1, where the elongate member comprises a non-circularcross-section.
 44. The access device of claim 43, where thecross-section of the elongate member is oval.
 45. The access device ofclaim 43, where the cross-section of the elongate member is rectangular.46. The access device of claim 43, where the elongate member comprisesat least a first planar surface. 47.-48. (canceled)
 49. The accessdevice of claim 46, where the distal end of the elongate membercomprises a slot in the planar surface.
 50. The access device of claim1, where the working channel of the elongate member comprises anon-circular shape having a height and width, such that the workingchannel width is not equal to the working channel height. 51.-97.(canceled)